PlainRecalls
FDA Devices Moderate Class II Terminated

Syngo Imaging XS is a Picture Archiving and Communication System (PACS)

Reported: December 30, 2015 Initiated: November 17, 2015 #Z-0550-2016

Product Description

Syngo Imaging XS is a Picture Archiving and Communication System (PACS)

Reason for Recall

For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo Imaging XS printer configuration file.

Details

Units Affected
42
Distribution
AL ; CA ; CO ; CT ; FL ; GA ; IA ; IL ; IN ; KS ; MD ; MI ; MO ; NC ; NE ; NJ ; NV ; NY ; OH ; PA ; TN ; TX ; WI ;
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Syngo Imaging XS is a Picture Archiving and Communication System (PACS). Recalled by Siemens Medical Solutions USA, Inc. Units affected: 42.
Why was this product recalled?
For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo Imaging XS printer configuration file.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 30, 2015. Severity: Moderate. Recall number: Z-0550-2016.